The FCA has recently adopted an interventionist approach in the area of patent validity in Sanofi-Aventis v Apotex 2013 FCA 186 (“Sanofi 2013”). The FCA overturned the trial court’s findings that Sanofi’s clopidogrel patent was invalid for inutility and obviousness. First, the trial judge was found to have erred in law in his construction of the patent by “reading in” a Promise that the FCA says was not there. Secondly, the trial judge appears to have erred in failing to properly apply the facts to the Sanofi SCC legal test for obviousness, and asked the critical wrong question in determining whether it was obvious to reach the invention.

Validity Analysis

There are a few key points on the substantive approach to utility and obviousness. On utility, Sanofi 2013 certainly reinforces the importance of the “Consolboard – type” Promise in a patent, but at the same time says that before the court can use the Promise as a measuring stick to determine whether utility has been made out, there must be an explicit Promise in the patent (para. 49). Even though Sanofi’s patent was a selection from a known genus, it is enough for the selection if there is an improvement over any aspect of the genus invention. In supporting reasons (arguably in obiter) Justice Gauthier questioned the disclosure requirement step of the sound prediction test (and appears to advance a position that a patentee may guess as to its stated Promise, and the public can only determine it was a baseless guess or a secretly sound one, once a patent is challenged).

Regarding obviousness, the FCA disagreed with the trial judge’s approach to framing the Apotex v. Sanofi 2008 SCC 61 (“Sanofi SCC”) questions. In the context of the facts of Sanofi’s enantiomer patent (ie. a compound selected from a known parent racemate of 2 compounds and other genus compounds), the “distance between the common general knowledge and the inventive concept … could not be bridged by routine experimentation since the results to be obtained were unknown “. The trial judge focused on whether it was obvious to try to resolve the racemate. The FCA disagreed with the trial judge’s starting point (the racemate and not other compounds in the prior genus patents), and his analysis of what a PSIA would do and why. (As an aside, it is curious that although the court dealt with both utility and obviousness, and acknowledged there may be instances where a patentee needs to put a Promise in its patent to “support a specific result included in the claims or an advantage that is necessary to support the invention described in the claim”, the FCA itself seems to have failed to consider this factor. The FCA focused on tests of the racemate/enantiomers in saying that Sanofi had conducted tests to determine the advantages for the selection. At the same time, there is no discussion of tests showing clopidogrel had advantages over the prior genus. There seems to be an inconsistency here. Sanofi has met its selection requirements by running tests on 3 compounds out of a starting genus of 250,000 compounds. At the same time, the PSIA must start from the genus compound, and not the 3 compounds. These 2 positions are difficult to reconcile.)

Procedural Implications

The more interesting implications of Sanofi 2013 are in fact the procedural issues underlying the FCA’s rather swift reasons in overturning the trial judge who heard 26 days of actual expert testimony. The trial court heard from experts on how a PSIA (to whom the patent is directed) would interpret the key Promise, and evaluate the nature of the work to be conducted in arriving at the invention of clopidogrel. In addition the trial judge heard from the inventors regarding their development of the invention.

In contrast, in Sanofi SCC, the case before the SCC was merely a “Notice of Compliance” matter, which is supposed to be a summary matter and is decided only on the basis of a few expert affidavits.

Notwithstanding these arguably critical factual and evidential differences, the FCA in Sanofi 2013 appears to express a strong desire to defer to the “summary” findings of the SCC 5 years earlier, and again uphold the validity of Sanofi’s patent just as the SCC did.

Regarding utility – this was not in issue in Sanofi SCC, however the SCC had identified the invention/inventive concept which the FCA in Sanofi 2013 appears to accept as a basis for the Promise, although this is not clearly reviewed (at para. 51). At the same time, the FCA accepted that although Promise construction is for the trial judge, “he is to read it and understand it as would the person skilled in the art. To that end, he has the evidence of experts as to how a person skilled in the art would understand the patent.” On its face it appears the FCA disagreed with the trial judge’s evaluation of the expert evidence, and the patent, to conclude that there was an explicit promise of effectiveness in humans. In view of the “frailty” of the trial judge’s conclusion, the FCA says there was a need for the trial judge to clearly explain why he saw an explicit promise. This latter comment may suggest that there were problems with the reasons of the trial judge that the FCA has used as its “hook” to ground its decision to overturn. The FCA’s criticism of the trial judge’s reasoning may also be applicable to certain efforts of the FCA to minimize the Promise to simply a potential use in humans, including their findings that the patent was directed at animal “patients” as well.

Regarding obviousness, the FCA’s initial comments are somewhat telling “It is worth remembering that the issue of obviousness was raised and rejected in Plavix. [Sanofi SCC]”. After briefly discounting any “new evidence” which may have been before the trial judge and not the SCC, the FCA concludes “the Trial Judge found himself in exactly the same position as did the Supreme Court when it decided Plavix”.

Effect on the Interplay of NOC cases and Actions

The Federal Court has frequently commented on the nature of the differences between an NOC case and full-fledged patent actions (see for example 2009 FC 711; 2006 FC 1234). At the same time, the FCA has commented on certain similar aspects at 2011 FCA 77 (although this was in the context of pleadings, the decision may certainly be relied on by some for more substantive arguments regarding the estoppel effect of a first NOC decision). In some cases a patentee has lost during an NOC case and won an infringement action; in other cases the reverse has occurred. Most recently, Apotex’s impeachment action was won on summary judgment after Pfizer lost its “summary” NOC case at the SCC (2012 SCC 60).

Perhaps the instances where an NOC case casts a “determining shadow” over a subsequent patent action are limited to initial cases involving the SCC (which are likely to be rare given the SCC does not generally grant leave in patent matters). In any case, the validity of Sanofi’s patent will come full circle once Apotex’s application for leave to the SCC is undoubtedly filed in the near future.